Kornimate/medical-research-clean huggingface dataset:
efficacy of the use of 3d printing models in the treatment of tibial plateau fractures: a randomized clinical trial

Conditions: Tibial Plateau Fracture

Summary: tibia3d is a randomized, open and prospective clinical trail that evaluates the use of preoperative 3d printing in the surgical treatment of patients with tibial plateau fractures

randomized, open and prospective study. once the surgical indication for osteosynthesis has been established after having suffered a tibial plateau fracture, the patients will be randomized in a 1:1 ratio to one of the tfollowing treatment groups: control group: images obtained by plain radiography and computed tomography are used in the planning of osteosynthesis of the tibial plateau fracture. experimental group: in the planning of tibial plateau fracture osteosynthesis, in addition to images obtained by plain radiography and computed tomography, a three-dimensional plastic model printed by processing the tomography images is used. patients (or their legal representatives) must sign the consent before randomization. after surgery, a follow-up will be carried out at 3, 6 and 12 months, visits in which data will be collected regarding the physical examination, radiological examination, pain and questionnaires will be filled out regarding the functionality of the knee and perception of health status.

Eligibility criteria:
inclusion criteria: * patients with tibial plateau fracture requiring surgical treatment. * age equal to or greater than 18 years. * signature of informed consent in writing according to current legislation before collecting any information. exclusion criteria: * pregnancy in progress. * presence of serious systemic pathology or another situation that contraindicates treatment * presence of other fractures in the ipsilateral femur or tibia that condition the surgical treatment of the tibial plateau fracture. * findings in the physical examination, in the results of the tests or other medical, social or psychopathological factors that, in the opinion of the investigators, could negatively influence the study. * inability to grant informed consent in the absence of a legal representative. * inability to follow instructions or collaborate during the development of the study.

Keywords: 3d printing tibial fracture
effects of losartan and antiretroviral regimen containing raltegravir in fibrosis inflammation mediators, cardiovascular risk and neurocognitive disorders in hiv infected patients previously effectively treated

Conditions: HIV-1 Infection

Summary: this is a open controlled trial in which 48 hiv-1 patients successfully treated with efv/ftc/tdf will be randomized to one of 4 groups in equal proportion between arms (1:1). the four arms are as follows: arm i: efv / ftc / tdf (n = 12) arm ii: efv / ftc / tdf + lst (n = 12) arm iii: ftc / tdf + mk-0518 (n = 12) arm iv: ftc / tdf + lst + mk-0518 (n = 12) the allocation will take place in two phases: phase i: 24 patients 1:1 receiving efv/ftc/tdf vs. efv/ftc/tdf + losartan if losartan arm shows benefits we will proceed to the second phase: phase ii: 24 patients 1:1 to receive ftc/tdf+ mk-0518 versus ftc/tdf + mk-0518 + losartan. patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in tl equal to or greater than 50%.


Eligibility criteria:
inclusion criteria: 1. patients older than 18 years. 2. patients with hiv infection in antiretroviral treatment with efv / ftc / tdf with undetectable viral load (vl \<37 copies) for at least 48 weeks. 3. nadir cd4 +\> 250 cells/mm3. 4. patients, properly informed, give their written consent to participate in the study. exclusion criteria: 1. criteria for patients with aids. 2. patients with active opportunistic diseases. 3. patients coinfected with hcv. 4. patients without tonsillar tissue. 5. treatment with other drugs receptor antagonists or angiotensin ii converting enzyme inhibitors, angiotensin ii. 6. kidney failure.(glomerular filtration rate (gfr \< 60 ml/mn) 7. severe liver failure (pt\> 60% ). 8. pregnant women 9. known hypersensitivity or contraindication to any study drug. 10. determination of blood pressure (bp) \<100/60 mmhg 11. hyponatremia with serum na numbers \<132 meq / l 12. history of chronic vomiting the last 6 months 13. history of chronic diarrhea the last 6 months
dinoprostone vs misoprostol before lng-iud insertion

Conditions: IUD Insertion Pain

Summary: the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to iud insertion in multiparous women regarding reduction in iud insertion pain


Eligibility criteria:
inclusion criteria: * multiparous women requesting iud insetion exclusion criteria: * active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
profiling the skin microbiome in response to altreno in acne patients

Conditions: Acne; Healthy

Summary: the study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to altreno monotherapy as compared to benzoyl peroxide (bpo) 2.5% leave-on gel monotherapy in acne patients.

with the advent of 16s rrna sequencing, scientific community is beginning to understand the critical importance of the microbiome in human health. in dermatology, researchers have begun to lead the effort to not only better understand how the microbiome contributes to the pathogenesis of skin disease, but also harness its power to develop novel therapies. acne is a common inflammatory skin disorder. p. acnes on the skin has been traditionally thought of as the culprit bacteria in the pathogenesis of acne. recent studies demonstrate that the skin microbial composition dynamically changes in response to systemic acne therapy. using 16 rrna gene sequencing, a prior study has confirmed that systemic antibiotic treatment decreased the abundance of p. acnes, which returned to baseline after discontinuation of the therapy. in contrast, the systemic therapy increased the abundance of pseudomonas species, which returned to baseline after therapy cessation. based on the opposing response to the therapy, it can be speculated that these two species compete for the same microenvironment within the skin microbiome. interestingly, the same systemic therapy decreased the abundance of lactobacillus genus, the "good bacteria" that is protective against skin infection, and that decrease was sustained even after cessation of the therapy. similarly, another study has demonstrated that systemic isotretinoin therapy disturbed the skin microbiome in acne patients with increased bacterial diversity on the cheeks. it is unclear the potential therapeutic role of the increased bacterial diversity in the management of acne patients. the study aims to characterize the shift in the diversity and abundance of the skin microbial community in response to altreno in acne patients. understanding the role of the skin microbiome in response to therapy can help clinicians to develop tailored, targeted treatment options, including reconstitution of "good bacteria." furthermore, it can lead to development of novel topical pre and probiotics.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of acne that warrants initiating topical medications. * denies use of any prescribed systemic acne treatments in the past 30 days. * denies use of any prescribed topical medications in the past 30 days. * denies use of any otc topical acne medications in the past 14 days. * denies use of any emollients in the past 24 hours (if feasible). * denies bathing or facial washing in the past 12 hours (if feasible). * willingness to adhere to the recommended topical regimen during the duration of the study. exclusion criteria: * women who are pregnant, breastfeeding, or planning to get pregnant during the study. * use of any investigational drug(s) in the past 3 months.
safety and tolerability of inhaled nitric oxide in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (no) when administered by nasal cannula over a 44 hour period to clinically stable cystic fibrosis (cf) subjects. toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (fev1), or an increase in methemoglobin.

cystic fibrosis (cf) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (cftr) protein. a cycle of chronic, persistent infections with cf-related pathogens and an excessive inflammatory response progressively damages the airways and lung parenchyma, resulting in widespread bronchiectasis and ultimately, respiratory failure. despite tremendous advances in understanding the cf gene and the cftr protein, it is not known exactly how mutations in the gene and defects in cftr lead to persistent airway infection and inflammation. inhaled nitric oxide (no) has potential to be an effective treatment in cf lung disease. inhaled no has been studied in other airways diseases characterized by infection and /or inflammation such as copd and idiopathic pulmonary fibrosis. no has been shown to activate cftr and alternative chloride channels, thereby increasing chloride current in epithelial cells. therefore, no treatment may be beneficial in individuals with cf.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * 12 years of age and older * fev1 greater than 40% of predicted * resting awake oxygen saturation of at least 88% * stable pulmonary disease as defined by both clinical impression and having had no recent hospitalizations or changes in antibiotic regimen within 1 month prior to enrollment * signed informed consent form exclusion criteria: * pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within 1 month of enrollment * isolation of b. cepacia from a respiratory tract culture within 6 months * severe nasal obstruction at the time of screening * receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment * pregnancy (a negative pregnancy test must be documented prior to enrollment if applicable) * patients who have received treatment with nitric oxide for inhalation within 24 hours prior to study initiation or other investigational medications within 24 hours.

Keywords: inhaled nitric oxide cystic fibrosis
intervention with lupin protein-enriched foods in hypercholesterolemic subjects

Conditions: Hypercholesterolemia

Summary: the objective of the study is to elucidate the effects of lupin protein (lupinus angustifolius boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein.

the study is based on a previous finding that a daily dosage of 25 g lupin protein isolate, administered as protein drinks, is capable to influence the plasma lipids positively. consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented daily. a double-blinded, controlled, randomized cross-over trial will be performed. altogether 75 volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each. after a run-in period (baseline), the first group will consume foods with lupin protein isolate (group a), the second group will receive the same foods with milk protein isolate (group b) and the third group will consume the foods with milk protein and 1,6 g arginine per day over a period of four weeks. after a wash-out period of six weeks, the diet will be crossed within the three groups for a second intervention period of four weeks. after another wash-out period, diet will be crossed within the three groups once again. arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the two groups receiving foods with milk protein. in the other groups (receiving foods with lupin protein or milk protein only) four placebo capsules will be served, containing mannitol.

Eligibility criteria:
inclusion criteria: * moderate hypercholesterolemia (total cholesterol \>= 5.2 mmol/l) * age: 20-80 years exclusion criteria: * intake of lipid-lowering pharmaceuticals * allergy against legumes * intolerance or allergy against milk * pregnancy, lactation * chronic bowel diseases

Keywords: dietary protein lupin protein cholesterol metabolism protein metabolism hypercholesterolemia protein-enriched foods
flibanserin (addyi®) vs. flibanserin and sex therapy

Conditions: Hypoactive Sexual Desire Disorder

Summary: unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.

this is an unblinded study to be conducted at a single research center, san diego sexual medicine. subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. responders will be determined by a score of 1-3 on the patient global impression of improvement (pgi-i) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.

Eligibility criteria:
inclusion criteria: 1. subject is willing and able to provide written informed consent and hipaa authorization before any study procedures are conducted; 2. subject is female; 3. subject is ≥18 years old; 4. subject has biologic-based hsdd as her primary sexual complaint; 5. subject scores \<26 on fsfi and \<4.8 on desire domain of fsfi at screening; 6. subject scores \>18 on fsds-dao; 7. subject answers yes to questions 1-4 on the dsds screener; 8. subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization); 9. subject agrees to comply with the study procedures and visits. exclusion criteria: 1. subject has sexual pain; 2. subject does not have generalized, acquired hsdd; 3. subject has used flibanserin in the last 6 months; 4. subject has history of alcohol or drug abuse; 5. subject uses tobacco in any form; 6. subject is currently using androgen therapy and unwilling to washout; 7. subject is pregnant, nursing, or planning to become pregnant over the next 6 months; 8. subject is taking a moderate or strong cytochrome p450 3a4 (cyp3a4) inhibitor; 9. subject is taking a cyp3a4 inducer; 10. p-glycoprotein substrate; 11. subject has a history of liver impairment; 12. subject has any chronic medical condition or psychologic disorder that the principal investigator feels makes her ineligible for the study; 13. subject has any condition or exhibits behavior that indicates to the principal investigator that the subject is unlikely to be compliant with study procedures and visits.

Keywords: hypoactive sexual desire disorder addyi flibanserin low sexual desire hsdd
length of tumour feeding artery after colon cancer surgery

Conditions: Colon Cancer

Summary: the quality of colon cancer surgery is highly debated these years since the mortality of the disease is not declining markedly. surgery is the main treatment of colon cancer and during surgery it is very important for the surgeon to remove the tumour and all potential ways of tumour spread. as colon cancer first of all spreads to the nearby lymph nodes lying along the tumour feeding artery the surgeon aims to cut the vessel as central as possible. this means that all of the tumour feeding artery should have been removed after surgery. in this study the investigators want to measure the length of the tumour feeding artery after surgery as a quality control of the surgery. the investigators hypothesize that the artery will be shorter than 5 mm. the investigators wish to ct scan all patients two days after colon cancer surgery and afterwards measure then length of the artery on the images. this study will not inflict with the normal routine for patient information and treatment.


Eligibility criteria:
inclusion criteria: * primary colon cancer exclusion criteria: * kidney failure, allergy to contrast, pregnancy

Keywords: colon cancer quality of surgery length of tumour feeding artery
reduction of ige antibody in human allergic subjects

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to determine whether a neuropeptide, substance p, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.

allergic rhinitis (hay fever) affects many children and adults and is a risk factor for development of asthma. this study utilizes the neurotransmitter, substance p, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. subjects will receive substance p and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.

Eligibility criteria:
inclusion criteria: * positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive * volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period exclusion criteria: * volunteer is pregnant or lactating * abnormal electrocardiogram for subjects over 50 years of age * use of beta adrenergic antagonists or tricyclic antidepressants

Keywords: substance p allergic rhinitis allergen immunotherapy
aquatic exercise for cognition and mobility in older adults

Conditions: Aging Well; Aging Problems; Cognitive Change; Gait, Unsteady; Mobility Limitation

Summary: the purpose of this study is to assess the effects of an aquatic exercise program on cognition and physical function of older adults.


Eligibility criteria:
inclusion criteria: * able to ambulate 100 ft independently with or without assistive device * score greater than or equal to 3 on the mini-cog test * stable medical condition within one month prior to the study * stable exercise program within one month prior to the study * available during study testing and group class times * covid-19 vaccination * permission from medical provider to participate in the study exclusion criteria: * history of dementia or alzheimer's * contraindication to exercise or pool immersion (e.g., unstable cardiovascular conditions, fever, diarrhea, aqua-phobia)

Keywords: aquatic exercise fall prevention functional mobility
pet/ct imaging of angiogenesis in lung or head and neck cancers prior or during chemotherapy with antiangiogenic agents

Conditions: Advanced Head and Neck Carcinoma; Advanced Non-small Cell Lung Carcinoma

Summary: the primary objective of this phase ii study is to evaluate the use of labelled rgd ligand in pet/ct to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect. the predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: recist 1.1 criteria for ct or mri, percist criteria for fdg pet/ct, clinical, endoscopic and histological findings.

prospective, multicentre, open label, phase ii clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18f or 68ga labelled rgd peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.

Eligibility criteria:
inclusion criteria: * 1a. male or female \> 18year old with non-small cell lung carcinoma (nsclc) meeting the following criteria : * advanced nsclc proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled * measurable lesions \> 1 cm in short axis. * pretherapeutic contrast-enhanced ct of thorax and upper abdomen available for masked reading on appropriate medium * fdg pet/ct available for masked reading on appropriate medium 1b. male or female \> 18year old with head and neck (h\&n) cancer meeting the following criteria: * advanced h\&n cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled * measurable lesions \> 1 cm in short axis. * pretherapeutic native and contrast enhanced ct or mri of the head and neck available for masked reading on appropriate medium * fdg pet/ct available for masked reading on appropriate medium * oto-rhino-laryngologic (orl) examination including orl fibroscopy and/or optionally panendoscopy. 2. capacity to remain without movement during the pet/ct examination 3. ecog performance status ≤ 2 at inclusion 4. patient with life expectancy ≥ 24 weeks after inclusion. 5. in fertile females, at inclusion the pregnancy must be ruled out 6. volunteer and capable to follow necessary instructions during the trial 7. informed consent signed by the patient 8. affiliation to a social security system exclusion criteria: - 1. in patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer. 2. scheduled treatment which does not include an antiangiogenic agent 3. patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. pregnancy or breastfeeding.

Keywords: angiogenesis integrins rgd pet/ct fdg pet/ct predictive value therapeutic response efficacy tolerability
the use of lidcoplus in fluid resuscitation decision-making

Conditions: Shock

Summary: unwell patients in the intensive care unit (icu) often need supplementary fluids to be given into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be harmful. it can sometimes be difficult to tell whether or not a patient will benefit from extra fluids so they are given a "fluid challenge", whereby a small volume of fluid is given quickly into the cannula and the change in their status is noted. if the patient's condition improves, this suggests that the patient is "fluid responsive" and needs more fluid. a lidcoplus haemodynamic monitor is a device used in the icu to estimate the amount of blood ejected from the heart on each heartbeat using pressure readings obtained from a tube placed in one of the patient's arteries (arterial line). the investigators aim to determine whether or not the use of this device called makes a difference to the judgement of "fluid responsiveness" when the patient is given a fluid challenge when compared to simply using measurements of pulse and blood pressure and assessing the circulation in the patient's limbs. this will allow the investigators to determine whether or not the lidcoplus alters the decisions made by doctors and nurses about how much fluid to give their patients and hence if it is of any benefit.


Eligibility criteria:
inclusion criteria: * adult patients * admitted to intensive care unit (icu) * undergoing fluid resuscitation guided by fluid challenges * monitored by a lidcoplus haemodynamic monitor attached to an arterial line exclusion criteria: * poor arterial line trace * moribund state * patient / relative refusal * contra-indication to fluid bolus

Keywords: intensive care units resuscitation fluid therapy vascular access devices cardiac output monitoring, physiologic